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Clinical Trials in the USA / NCT07801066
Recruiting Phase 4

Testing Healthy Participants for Drowsiness After Single Dosing of Two Different Doses of Muscle Relaxer

NCT07801066 · tracked via the Priya Life Science USA tracker
Sponsor
Primus Pharmaceuticals
Phase
Phase 4
Started
2026-10-15
Last updated
2026-11-05

Condition(s) studied

Healthy Participants

Investigational drug(s) / intervention(s)

Metaxalone 640 mg →Metaxalone 800 MG →

Metaxalone 640 mg: Dose micronized 640 mg

Metaxalone 800 MG: The dose is 800 mg

Study summary

Health participants take a single dose, perform testing, washout for one week, take a single dose of different formulation, and perform testing for comparison of the 2 doses.

Eligibility

Sex
ALL
Min age
18 Years
Max age
55 Years
Healthy volunteers
Accepted
Inclusion Criteria: * Healthy adults aged 18 to 55 years old * Weigh at least 120 pounds * Medically healthy * Able to sign and date informed consent form Exclusion Criteria: * Current use of any medications known to affect the sleep-wake cycle * Sleep disorder diagnosis * Positive urine test for drugs * Known history of alcohol use disorder * Having a history of cognitive disorders, depression, schizophrenia, panic disorder, or dementia * Having difficulty eating high fat meal * Participants who are pregnant, nursing or intending to become pregnant during the period of study. * Blood Pressure \> 160/110 or \<90/50 mmHg. * Heart Rate \>100 or \< 50/ beats per minute. * Having a history of seizure disorder or epilepsy.

Primary outcome measure(s)

  • Change from baseline to approximately 4 hours post-dose, in mean reaction time to a stimulus as measured in milliseconds by the Reaction Time Test (RTT) — Baseline dose to four (4 ) hours post-dose
    Measures the time between a visual stimulus and response, measured in milliseconds
  • Change from baseline to approximately 4 hours post-dose of delayed response exceeding a predefined threshold >300 ms as measured by the Reaction Time Test (RTT) — Baseline dose to approximately 4 hours post-dose
    measures the time between a visual stimulus and response, measured in milliseconds

Trial sites (1)

FacilityCityRegionStatus
AMR Clinical - Columbus Columbus Ohio Recruiting

More Primus Pharmaceuticals trials in the USA

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A Study to Learn How Different Forms of the Study Medicine Called Berobenatide is Taken up Into the Blood in Adults With Overweight or Obesity Starting soon
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07801066 on ClinicalTrials.gov ↗ ← All trials in the USA